Copyright © 2007 by PharmEcology Associates, LLC John Brenna, R. Ph. Hospital Consultant...

Copyright © 2007 by PharmEcology Associates, LLCCopyright © 2007 by PharmEcology Associates, LLC

John Brenna, R. Ph.John Brenna, R. Ph.Hospital ConsultantHospital Consultant

PharmEcology Associates, LLCPharmEcology Associates, [email protected]@pharmecology.com

www.pharmecology.comwww.pharmecology.com414-292-3959414-292-3959

Implementing a Implementing a Pharmaceutical Waste Pharmaceutical Waste Management SystemManagement System

Compliance and Pollution Prevention WorkshopCompliance and Pollution Prevention WorkshopKansas CityKansas City

December 6December 6thth, 2007, 2007

Copyright 2007 PharmEcology Associates, LLCCopyright 2007 PharmEcology Associates, LLC

GoalsGoals

To develop a better understanding of the To develop a better understanding of the regulatory and environmental reasons for regulatory and environmental reasons for managing pharmaceutical waste more managing pharmaceutical waste more stringentlystringently

To review the definitions of a hazardous waste To review the definitions of a hazardous waste as they apply to waste pharmaceuticalsas they apply to waste pharmaceuticals

To explore implementation models for the To explore implementation models for the management of hazardous pharmaceutical management of hazardous pharmaceutical wastewaste


Who Are the Regulators?Who Are the Regulators? USEPA & 10 RegionsUSEPA & 10 Regions

Office of Solid Waste, Hazardous Waste DivisionOffice of Solid Waste, Hazardous Waste Division Office of WaterOffice of Water

Authorized State Hazardous Waste ProgramsAuthorized State Hazardous Waste Programs Every state except Iowa and AlaskaEvery state except Iowa and Alaska

Local Publicly Owned Treatment Works Local Publicly Owned Treatment Works (POTWs)(POTWs) Must meet federal effluent guidelinesMust meet federal effluent guidelines

The Joint Commission The Joint Commission Primary accrediting body for many hospitalsPrimary accrediting body for many hospitals Federal funding dependent on accreditationFederal funding dependent on accreditation


USGS Water Quality Study*USGS Water Quality Study* First nationwide reconnaissance of occurrence of First nationwide reconnaissance of occurrence of

pharmaceuticals, hormones, other organic wastewater pharmaceuticals, hormones, other organic wastewater contaminants – March, 2002contaminants – March, 2002

139 streams in 30 states, analyzed for 95 different OWCs139 streams in 30 states, analyzed for 95 different OWCs 82 of the 95 detected in at least one sample82 of the 95 detected in at least one sample One or more OWCs found in 80% of stream samplesOne or more OWCs found in 80% of stream samples 13% of sites had more than 20 OWCs13% of sites had more than 20 OWCs Minnesota Study: Found 79 out of 92; 23 were Minnesota Study: Found 79 out of 92; 23 were

pharmaceuticalspharmaceuticals

**http://toxics.usgs.gov/pubs/OFR-02-94/index.htmlhttp://toxics.usgs.gov/pubs/OFR-02-94/index.html


Below the Dose/Response Curve:Below the Dose/Response Curve:Endocrine DisruptorsEndocrine Disruptors

Endocrine Disruptors: chemicals that interfere with the Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles)including thyroid, adrenals, ovaries, testicles)

Mimic hormone, trigger identical response, block a Mimic hormone, trigger identical response, block a hormonehormone

Do not follow the normal dose/response curve Do not follow the normal dose/response curve Active at much lower doses, especially in the fetus and Active at much lower doses, especially in the fetus and

newbornnewborn Estradiols, progesterone, testosteroneEstradiols, progesterone, testosterone LindaneLindane


The Faroes StatementThe Faroes Statement200 environmental scientists from five continents met 200 environmental scientists from five continents met at the Faroes Islands in the North Atlantic –May 24, at the Faroes Islands in the North Atlantic –May 24, 20072007Warned of fetal exposure to toxic substances resulting Warned of fetal exposure to toxic substances resulting in “fetal programming” to the 2in “fetal programming” to the 2ndnd and 3 and 3rdrd generation generationLifelong effects: obesity, diabetes, cancers, ADHD, Lifelong effects: obesity, diabetes, cancers, ADHD, Parkinson’s, Alzheimer’s, reduced immune system Parkinson’s, Alzheimer’s, reduced immune system ““The dose makes the poison” replaced by “The timing The dose makes the poison” replaced by “The timing makes the poison” makes the poison” New approach to testing of chemicals strongly New approach to testing of chemicals strongly advocated; 80% of major chemicals never tested for advocated; 80% of major chemicals never tested for damage to early development damage to early development http://www.precaution.org/lib/rpr-html.htmhttp://www.precaution.org/lib/rpr-html.htm


"When an activity raises threats of harm to "When an activity raises threats of harm to human health or the environment, human health or the environment, precautionary measures should be taken precautionary measures should be taken even if some cause and effect even if some cause and effect relationships are not fully established relationships are not fully established scientifically." Wingspread Conference, scientifically." Wingspread Conference, Racine, WI 1998Racine, WI 1998


Preliminary 2008 Effluent Guidelines Preliminary 2008 Effluent Guidelines Program Plan Program Plan

(Pre-publication version)(Pre-publication version) Published in Federal Register Oct. 18Published in Federal Register Oct. 18 thth, 2007, 2007 Major pollutants of concern in discharges include Major pollutants of concern in discharges include

pharmaceuticals and endocrine-disrupting pharmaceuticals and endocrine-disrupting compounds (EDCs) compounds (EDCs)

Focus area: Unused pharmaceuticals Focus area: Unused pharmaceuticals Physician offices, long-term care facilities, veterinary Physician offices, long-term care facilities, veterinary

care services, hospitals and clinicscare services, hospitals and clinics

Soliciting data, information, and comments on a Soliciting data, information, and comments on a variety of questions relating to disposal of variety of questions relating to disposal of unused pharmaceuticalsunused pharmaceuticals


What is the Scope of the Study?What is the Scope of the Study? Highlight good voluntary practices on an industry that may have Highlight good voluntary practices on an industry that may have

significant discharges of consequence to the environmentsignificant discharges of consequence to the environment Focus includeFocus include unused or expired pharmaceutical discharges to unused or expired pharmaceutical discharges to

municipal wastewater treatment plants from hospitals, long-term municipal wastewater treatment plants from hospitals, long-term care facilities, and veterinarianscare facilities, and veterinarians

What are They Studying?What are They Studying? Current industry practices, guidance and regulatory requirementsCurrent industry practices, guidance and regulatory requirements Source, and pass through or inhibition, associated with these Source, and pass through or inhibition, associated with these

discharges at municipal wastewater treatment plantsdischarges at municipal wastewater treatment plants Schedule:Schedule:

CY2007: Complete data collection for identifying current industry CY2007: Complete data collection for identifying current industry practices, existing guidance/requirements, and possible BMPspractices, existing guidance/requirements, and possible BMPs

FY2008: Estimate pollutant loadings, identify possible best practices for FY2008: Estimate pollutant loadings, identify possible best practices for controlling pollutant discharges and associated costs, and final report.controlling pollutant discharges and associated costs, and final report.

EPA’s Clean Water Act Review of the EPA’s Clean Water Act Review of the Management of Unused Pharmaceuticals for the Management of Unused Pharmaceuticals for the

Health Services Industrial SectorHealth Services Industrial Sector


Increasing USEPA Increasing USEPA Regulatory ActivityRegulatory Activity

Region 1(New England)Region 1(New England) Veterans Administration Hospital, White River, Veterans Administration Hospital, White River,

Vermont, August 5Vermont, August 5thth, 2005 cited and fined , 2005 cited and fined $372,254 for hazardous waste violations$372,254 for hazardous waste violations

Region 2 (NY, NJ): Region 2 (NY, NJ): North Shore University Hospital, Manhasset, NY North Shore University Hospital, Manhasset, NY

fined $40,000 (July 2003)fined $40,000 (July 2003) Nassau University Medical Center, East Meadow, Nassau University Medical Center, East Meadow,

NY fined $279,900 (Oct. 2003)NY fined $279,900 (Oct. 2003) Mountainside Hospital, Montclair, NJ fined Mountainside Hospital, Montclair, NJ fined

$64,349 (Nov. 2003) $64,349 (Nov. 2003) Memorial Sloan Kettering Cancer Center, New Memorial Sloan Kettering Cancer Center, New

York , NY, fined $214,420York , NY, fined $214,420


Additional USEPA Additional USEPA Regional ActivityRegional Activity

Region 3: PA, VA, WV, DE, MD, DCRegion 3: PA, VA, WV, DE, MD, DC Located in Philadelphia, sponsored workshops in 2006Located in Philadelphia, sponsored workshops in 2006

Region 4: KY, TN, NC, SC, FL, GA, MS, ALRegion 4: KY, TN, NC, SC, FL, GA, MS, AL Inspections in GA, AL, possibly additional states Inspections in GA, AL, possibly additional states

Region 5: OH, IN, IL, WI, MN, MIRegion 5: OH, IN, IL, WI, MN, MI Site visits to hospitals in MN and WISite visits to hospitals in MN and WI

Region 7: IA, MO, KS, NERegion 7: IA, MO, KS, NE Sponsored seminars in 2006 & 2007; have been inspecting Sponsored seminars in 2006 & 2007; have been inspecting

hospitals in Kansas City and St. Louishospitals in Kansas City and St. Louis Region 8: ND, SD, MT, WY, UT, CO Region 8: ND, SD, MT, WY, UT, CO

Sponsored SD DENR workshopSponsored SD DENR workshop Region 9: AZ, NV, CARegion 9: AZ, NV, CA

Inspecting hospitals in CaliforniaInspecting hospitals in California


Relationship to Relationship to The Joint Commission Standards:The Joint Commission Standards:

Environment of CareEnvironment of Care Standard EC.3.10Standard EC.3.10 The organization manages The organization manages itsits hazardous materials and waste hazardous materials and waste[1][1]

risks. risks.

[1][1] Hazardous materials (HAZMAT) and waste: Hazardous materials (HAZMAT) and waste: Materials whose handling, use, and storage are guided or regulated Materials whose handling, use, and storage are guided or regulated

by local, state, or federal regulation. Examples include OSHA’s by local, state, or federal regulation. Examples include OSHA’s Regulations for Bloodborne Pathogens (regarding the blood, other Regulations for Bloodborne Pathogens (regarding the blood, other infectious materials, contaminated items which would release blood infectious materials, contaminated items which would release blood or other infectious materials, or contaminated sharps), the Nuclear or other infectious materials, or contaminated sharps), the Nuclear Regulatory Commission's regulations for handling and disposal of Regulatory Commission's regulations for handling and disposal of radioactive waste, management of hazardous vapors (such as radioactive waste, management of hazardous vapors (such as glutaraldehyde, ethylene oxide, and nitrous oxide),glutaraldehyde, ethylene oxide, and nitrous oxide), chemicals chemicals regulated by the EPA, Department of Transportation regulated by the EPA, Department of Transportation requirementsrequirements, and hazardous energy sources (for example, , and hazardous energy sources (for example, ionizing or non-ionizing radiation, lasers, microwaves, and ionizing or non-ionizing radiation, lasers, microwaves, and ultrasound.) ultrasound.)


OSHA Hazardous DrugsOSHA Hazardous Drugs NIOSH Hazardous Drug AlertNIOSH Hazardous Drug Alert

Hazardous drugs as defined by OSHA/NIOSH Hazardous drugs as defined by OSHA/NIOSH intersect but are not the same as EPA hazardous intersect but are not the same as EPA hazardous wasteswastes

ASHP Guidelines on Handling Hazardous DrugsASHP Guidelines on Handling Hazardous Drugs Deal primarily with OSHA employee exposure issues Deal primarily with OSHA employee exposure issues

but also refer to required or recommended hazardous but also refer to required or recommended hazardous pharmaceutical waste management practices pharmaceutical waste management practices


Hazardous Drugs vs. Hazardous WasteHazardous Drugs vs. Hazardous WasteWhere OSHA & EPA MeetWhere OSHA & EPA Meet

- Genotoxicity- Teratogenicity- Reproductive toxicity- Carcinogenicity- Organ toxicity at low doses

Examples: - Chemotherapy agents- Endocrine disruptors

OSHAHAZARDOUS DRUGS

EPAHAZARDOUS WASTE

P&U Listed Examples:- Epinephrine base- Warfarin- Nicotine

Characteristic Examples: - Formulations containing greater than or equal to 24% alcohol- Formulations containing heavy metals- Strong acids & bases

EPA TOXICHAZARDOUS

DRUG EXAMPLES

- Arsenic trioxide- Cyclophosphamide- Mitomycin- Melphalan

- Paclitaxel- Valrubicin- Etoposide

EPA IGNITABLEHAZARDOUS

DRUG EXAMPLES


How is Pharmaceutical Waste How is Pharmaceutical Waste Generated at the Healthcare Facility?Generated at the Healthcare Facility?

IV PreparationIV Preparation General CompoundingGeneral Compounding Spills/BreakageSpills/Breakage Partially Used VialsPartially Used Vials Partially Used Syringes/IVsPartially Used Syringes/IVs

If Contaminated, BiohazardousIf Contaminated, Biohazardous Discontinued, Unused PreparationsDiscontinued, Unused Preparations Unused Repacks (Unit Dose)Unused Repacks (Unit Dose) Patients’ Personal MedicationsPatients’ Personal Medications Outdated PharmaceuticalsOutdated Pharmaceuticals


When is an Outdated Drug When is an Outdated Drug a Waste?a Waste?

At the time and place the decision is made to At the time and place the decision is made to discard itdiscard it

Two EPA guidance letters to the industry:Two EPA guidance letters to the industry: Merck & Co., 1981Merck & Co., 1981 BFI Pharmaceutical, 1991BFI Pharmaceutical, 1991

Enables shipping of potentially usable Enables shipping of potentially usable outdates to a reverse distributor as productoutdates to a reverse distributor as product

PROHIBITS the shipping of waste-like items, PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials, expired such as unused IVs, partial vials, expired repacks, samplesrepacks, samples

Hospital is liable for using due diligence in Hospital is liable for using due diligence in selecting a vendorselecting a vendor


Non-returnable Waste

Returnable Expired Product


RCRA: RCRA: The Defining RegulationThe Defining Regulation

Resource Conservation & Recovery ActResource Conservation & Recovery Act Enacted in 1976, enforced by the EPAEnacted in 1976, enforced by the EPA Federal regulation of the disposal of solid Federal regulation of the disposal of solid

wasteswastes Encourages the minimization of waste Encourages the minimization of waste

generationgeneration Defines “hazardous waste”Defines “hazardous waste” ““Cradle to Grave” tracking of Cradle to Grave” tracking of

hazardous wastehazardous waste


RCRA Risk Management RCRA Risk Management & Liability& Liability

Civil and criminal liabilityCivil and criminal liability Civil: State/USEPA enforcementCivil: State/USEPA enforcement Criminal: FBI, Attorney General, Grand JuryCriminal: FBI, Attorney General, Grand Jury

Corporate fines: $32,500/violation/dayCorporate fines: $32,500/violation/day Personal liability: fines and/or Personal liability: fines and/or

imprisonmentimprisonment No statute of limitations No statute of limitations Managers up through CEO liableManagers up through CEO liable

http://www.epa.gov/compliance/resources/policies/criminal/exercise.pdfhttp://www.epa.gov/compliance/resources/policies/criminal/exercise.pdf


Healthcare RCRA ViolationsHealthcare RCRA Violations

Breakout of RCRA Violations from Hospital Disclosures

Generator Requirements12%

ID of HW 23%

Universal Waste18%

General Facility Standards16%

Container Management21%

UST 2%

Accumulation Time2% Manifest 6%

Slide courtesy of John Gorman, USEPA Region 2


Which Discarded Drugs Become Which Discarded Drugs Become RCRA Hazardous Waste?RCRA Hazardous Waste?

P-listed chemicals P-listed chemicals Sole active ingredient; unused; and empty Sole active ingredient; unused; and empty

containerscontainers

U-listed chemicalsU-listed chemicals Sole active ingredient; unusedSole active ingredient; unused

Characteristic of hazardous wasteCharacteristic of hazardous waste IgnitabilityIgnitability ToxicityToxicity CorrosivityCorrosivity ReactivityReactivity


Examples of P-Listed Examples of P-Listed Pharmaceutical WastePharmaceutical Waste

Arsenic trioxideArsenic trioxide P012P012 Epinephrine base*Epinephrine base* P042P042 NicotineNicotine P075P075 Nitroglycerin** (weak)Nitroglycerin** (weak) P081P081 Phentermine (CIV)Phentermine (CIV) P046P046 Physostigmine Physostigmine P204P204 Physostigmine SalicylatePhysostigmine Salicylate P188P188 Warfarin >0.3%Warfarin >0.3% P001P001

*Salts excluded federally as of Oct. 16*Salts excluded federally as of Oct. 16thth, 2007; States may or , 2007; States may or may not accept this positionmay not accept this position

** Excluded from the P list federally and in a number of states** Excluded from the P list federally and in a number of states


Examples of Examples of P-Listed P-Listed

PharmaceuticalsPharmaceuticals


Examples of U-listed Examples of U-listed Pharmaceutical WastePharmaceutical Waste

Chloral Hydrate(CIV)Chloral Hydrate(CIV) U034U034

ChlorambucilChlorambucil U035U035

CyclophosphamideCyclophosphamide U058U058

DaunomycinDaunomycin U059U059

DiethylstilbestrolDiethylstilbestrol U089U089

MelphalanMelphalan U150U150

Mitomycin CMitomycin C U010U010

StreptozotocinStreptozotocin U206U206

LindaneLindane U129U129

SaccharinSaccharin U202U202

Selenium SulfideSelenium Sulfide U205U205

Uracil MustardUracil Mustard U237U237

Warfarin<0.3%Warfarin<0.3% U248U248


Examples of U-Listed

Pharmaceuticals


Characteristic of IgnitabilityCharacteristic of Ignitability Aqueous Solution Aqueous Solution

containing 24% alcohol or containing 24% alcohol or more by volume & flash more by volume & flash point<140° Fpoint<140° F

Non-aqueous solutions Non-aqueous solutions with flash points <140 ° Fwith flash points <140 ° F

OxidizersOxidizers Flammable aerosolsFlammable aerosols Hazardous Waste Hazardous Waste

Number: D001Number: D001 Rubbing AlcoholRubbing Alcohol Topical PreparationsTopical Preparations InjectionsInjections


Characteristic of CorrosivityCharacteristic of Corrosivity

An aqueous solution having a pH < or = 2 An aqueous solution having a pH < or = 2 or > or = to 12.5or > or = to 12.5

Examples: Primarily compounding Examples: Primarily compounding chemicalschemicals Glacial Acetic AcidGlacial Acetic Acid Sodium HydroxideSodium Hydroxide

Hazardous waste number: D002Hazardous waste number: D002


Characteristic of ToxicityCharacteristic of Toxicity 40 chemicals which must be below specific leaching 40 chemicals which must be below specific leaching

concentrationsconcentrations Must pass the Toxicity Characteristic Leaching Must pass the Toxicity Characteristic Leaching

Procedure (TCLP)Procedure (TCLP) Must evaluate IVs, such as TPN (total parenteral Must evaluate IVs, such as TPN (total parenteral

nutrition)– may come out of regulation due to dilutionnutrition)– may come out of regulation due to dilution Examples of potential toxic pharmaceuticals:Examples of potential toxic pharmaceuticals: ArsenicArsenic m-Cresolm-Cresol Barium Barium Mercury (thimerosal,Mercury (thimerosal, CadmiumCadmium phenylmercuric acetate)phenylmercuric acetate) ChromiumChromium Selenium Selenium LindaneLindane SilverSilver


Preservatives: thimerosal & m-cresol

Heavy Metals: Selenium, Chromium and Silver

Examples of Pharmaceuticals Exhibiting the Characteristic of

Toxicity


Characteristic of ReactivityCharacteristic of Reactivity

Meet eight separate criteria identifying certain explosive Meet eight separate criteria identifying certain explosive and water reactive wastesand water reactive wastes

Nitroglycerin formulations may be considered excluded Nitroglycerin formulations may be considered excluded federally from the P081 listing as non-reactive as of federally from the P081 listing as non-reactive as of August 14, 2001 under FR: May 16, 2001, unless they August 14, 2001 under FR: May 16, 2001, unless they exhibit another characteristics, such as ignitability. exhibit another characteristics, such as ignitability.

Many, but not all states, have adopted the federal Many, but not all states, have adopted the federal exclusion for nitroglycerin. Waste must still be evaluated exclusion for nitroglycerin. Waste must still be evaluated for ignitability. for ignitability.

Hazardous Waste Number for reactives: D003Hazardous Waste Number for reactives: D003


Chemotherapy Agents: Many Are Chemotherapy Agents: Many Are Not Regulated by RCRA Not Regulated by RCRA

Eight chemotherapy agents are U-listed; one is Eight chemotherapy agents are U-listed; one is P-listed P-listed

About 100 chemotherapy agents not regulated About 100 chemotherapy agents not regulated by EPAby EPA

Examples:Examples: Alkylating agents: Cisplatin, ThiotepaAlkylating agents: Cisplatin, Thiotepa Antimetabolites: Fluorouracil, MethotrexateAntimetabolites: Fluorouracil, Methotrexate Hormonal (antiandrogen): LupronHormonal (antiandrogen): Lupron® (leuprolide)® (leuprolide) Hormonal (antiestrogen): TamoxifenHormonal (antiestrogen): Tamoxifen Mitotic Inhibitor: Taxol® (paclitaxol) Mitotic Inhibitor: Taxol® (paclitaxol)


Two Types of Two Types of Chemotherapy WasteChemotherapy Waste

Trace Chemotherapy WasteTrace Chemotherapy Waste Medical waste hauler protocols for “Chemo Waste”Medical waste hauler protocols for “Chemo Waste” Empty vials, syringes, IV’sEmpty vials, syringes, IV’s Treated as infectious medical waste preferably Treated as infectious medical waste preferably

through regulated medical waste incinerationthrough regulated medical waste incineration

““Bulk” Chemotherapy WasteBulk” Chemotherapy Waste If not empty, should be placed into Hazardous If not empty, should be placed into Hazardous

Waste containerWaste container


Definition of “Empty”Definition of “Empty”

““P” ListP” ListContainers of “P” listed chemicals are considered Containers of “P” listed chemicals are considered hazardous waste, unless they have been rinsed three hazardous waste, unless they have been rinsed three times and the rinsate discarded as hazardous waste.times and the rinsate discarded as hazardous waste.

““U” ListU” ListContainers of “U” listed chemicals are empty only Containers of “U” listed chemicals are empty only whenwhen

All contents removed that can be removed through All contents removed that can be removed through normal meansnormal means

And no more than 3% by weight remainsAnd no more than 3% by weight remains Example: “Empty” Cytoxan vial would be “trace” Example: “Empty” Cytoxan vial would be “trace”

chemotherapychemotherapy


What Is PharmEWhat Is PharmE HazardousHazardous®® Waste? Waste?

Drugs which may cause harm to human health or the Drugs which may cause harm to human health or the environment and need to be managed according to BMPsenvironment and need to be managed according to BMPs

NIOSH NIOSH Hazardous Drug Alert Appendix A

The US Department of Health and Human Services National The US Department of Health and Human Services National Toxicology Program's Toxicology Program's Report on Carcinogens (11th Edition)

Drugs with LD50s at or below 50mg/kgDrugs with LD50s at or below 50mg/kg

Endocrine disruptorsEndocrine disruptors

BMP recommendation is to segregate at least chemo agents BMP recommendation is to segregate at least chemo agents into RCRA toxic hazardous waste containers and to dispose of into RCRA toxic hazardous waste containers and to dispose of other agents through incinerationother agents through incineration


Federal Waste Federal Waste Generation StatusGeneration Status

Large Quantity Generator (LQG): generates more Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste than 1000 kg/month of hazardous waste or >1 or >1 kg/month “P” listed waste.kg/month “P” listed waste.

Small Quantity Generator (SQG):Generates <1000 Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste.or = 1 kg/month “P” listed waste.

Conditionally Exempt Small Quantity Generator Conditionally Exempt Small Quantity Generator (CESQG) : Generates < or = 100 kg haz (CESQG) : Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/monthwaste/month, < or = 1kg P listed waste/month


Documenting Generator StatusDocumenting Generator Status

Large quantity generator: no need to Large quantity generator: no need to record P waste separately.record P waste separately.

Small quantity generator or CESQG: need Small quantity generator or CESQG: need to segregate all P-listed including empty to segregate all P-listed including empty containers and document weights per containers and document weights per calendar monthcalendar month

Cannot exceed 1 kg or 2.2 lbs/month for Cannot exceed 1 kg or 2.2 lbs/month for any given monthany given month


How Should RCRA Hazardous How Should RCRA Hazardous Waste be Handled? Waste be Handled?

Need one or two new waste streams in Pharmacy, Need one or two new waste streams in Pharmacy, certain Patient Care Areas, Oncology Clinicscertain Patient Care Areas, Oncology Clinics

RCRA Hazardous Waste: ToxicRCRA Hazardous Waste: Toxic P, U, toxic Ds, (all Chemotherapy Residues, P, U, toxic Ds, (all Chemotherapy Residues,

Chemo Spills)Chemo Spills)

RCRA Hazardous Waste: Ignitable (D001)RCRA Hazardous Waste: Ignitable (D001)

May be able to combine these into one waste May be able to combine these into one waste stream based on state and waste vendor stream based on state and waste vendor requirementsrequirements


Empty vials, syringes, IVs,

tubing, gowns, gloves,etc.

Bulk chemo in vials, unused IV’s, P, U. toxic D

Traditional Chemo Waste Containers

New Hazardous Waste

Containers

Covidien/Kendall


How Should RCRA Hazardous How Should RCRA Hazardous Waste Be Disposed?Waste Be Disposed?

Either contract with a hazardous waste broker or Either contract with a hazardous waste broker or develop internal expertise for:develop internal expertise for: LabelingLabeling Waste profilingWaste profiling Manifest preparationManifest preparation Land ban preparationLand ban preparation

Contract with a federally permitted RCRA hazardous Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage waste incineration facility (TSDF: Treatment, Storage & Disposal Facility)& Disposal Facility)


How Should Non-hazardous Drugs be How Should Non-hazardous Drugs be Handled, Stored and Disposed?Handled, Stored and Disposed?

BMPs strongly discourage sewering and landfilling of BMPs strongly discourage sewering and landfilling of non-hazardous drugsnon-hazardous drugs

Organization can minimize risks by adopting BMPsOrganization can minimize risks by adopting BMPs Possible exception: controlled substances due to Possible exception: controlled substances due to

difficulty in rendering non-recoverable under Drug difficulty in rendering non-recoverable under Drug Enforcement Administration (DEA) regulationsEnforcement Administration (DEA) regulations

Consider segregating into white Covidien container with Consider segregating into white Covidien container with blue top Label “Incinerate Only”blue top Label “Incinerate Only”

Dispose at a regulated medical waste incinerator or Dispose at a regulated medical waste incinerator or municipal incinerator that is permitted to accept non-municipal incinerator that is permitted to accept non-hazardous pharmaceutical wastehazardous pharmaceutical waste


A Quick Primer on A Quick Primer on IncineratorsIncinerators

MunicipalMunicipal Permitted to burn municipal “garbage”Permitted to burn municipal “garbage” Usually not permitted to handle infectious wasteUsually not permitted to handle infectious waste May be permitted to handle non-hazardous May be permitted to handle non-hazardous

pharmaceuticals, with certain volume restrictionspharmaceuticals, with certain volume restrictions Medical WasteMedical Waste

Permitted by USEPA and the state to accept pathology Permitted by USEPA and the state to accept pathology waste, red bag and red sharps waste, trace chemo wastewaste, red bag and red sharps waste, trace chemo waste

May be permitted to accept non-hazardous pharmaceutical May be permitted to accept non-hazardous pharmaceutical wastewaste

Hazardous WasteHazardous Waste Permitted by USEPA, known as a Treatment, Storage and Permitted by USEPA, known as a Treatment, Storage and

Disposal Facility (TSDF)Disposal Facility (TSDF) High temperature, molecular bonds brokenHigh temperature, molecular bonds broken Authorized to accept the “worst of the worst” hazardous Authorized to accept the “worst of the worst” hazardous

chemicals, shipped on a 6-part Uniform Manifestchemicals, shipped on a 6-part Uniform Manifest


Common Pharmaceutical Waste Common Pharmaceutical Waste Stream ManagementStream Management

Type of Waste Type of Waste ContainerContainer

Color codeColor code ContentsContents TreatmentTreatment

MethodMethod

Red bag (non-Red bag (non-pathology)pathology)

RedRed Biohazardous Biohazardous (RMW) + Rx(RMW) + Rx

Autoclave/Autoclave/

LandfillLandfill

Red sharps/Red sharps/

needleboxneedlebox

RedRed Biohazardous; Biohazardous; needles, etc. + needles, etc. + RxRx


LandfillLandfill

Trace chemo RxTrace chemo Rx Yellow or WhiteYellow or White Bulk & Trace Bulk & Trace Chemo, Chemo, needles, tubingneedles, tubing

RMW RMW IncinerationIncineration

SewerSewer Unused IVs, Unused IVs, tablets, etc.tablets, etc.

Wastewater Wastewater Treatment PlantTreatment Plant

Municipal TrashMunicipal Trash Unused Unused ointments, etc.ointments, etc.

LandfillLandfill


Pharmaceutical Waste Pharmaceutical Waste Management RecommendationsManagement Recommendations

Type of WasteType of Waste

ContainerContainer

Color codeColor code ContentsContents TreatmentTreatment

MethodMethod

Red bag (non-Red bag (non-pathology)pathology)

RedRed Biohazardous Biohazardous (RMW) No Rx(RMW) No Rx


LandfillLandfill

Red sharps/Red sharps/

needleboxneedlebox

RedRed Biohazardous; Biohazardous; needles, No Rxneedles, No Rx


LandfillLandfill

Trace chemo RxTrace chemo Rx Yellow or WhiteYellow or White Biohazardous & Biohazardous & Trace ChemoTrace Chemo


RCRA Toxic RCRA Toxic

Hazardous RxHazardous Rx

BlackBlack RCRA & BMP RCRA & BMP Hazardous RxHazardous Rx

RCRA TSDF RCRA TSDF

RCRA IgnitableRCRA Ignitable

Hazardous RxHazardous Rx

BlackBlack RCRA RCRA Hazardous RxHazardous Rx

RCRA TSDFRCRA TSDF

Non-hazardous Non-hazardous RxRx

White/BlueWhite/Blue Non-hazardous Non-hazardous RxRx



Satellite AccumulationSatellite Accumulation Segregated, labeled and contained in areas where it is Segregated, labeled and contained in areas where it is

generatedgenerated Available in all units in which hazardous waste is Available in all units in which hazardous waste is

generated & must be under the control of the operatorgenerated & must be under the control of the operator Label each container as “Hazardous Waste” with the Label each container as “Hazardous Waste” with the

appropriate waste stream noted appropriate waste stream noted No time limit to fill the containerNo time limit to fill the container No more than 55 gallons of U listed and characteristic No more than 55 gallons of U listed and characteristic

waste or waste or 1 quart1 quart of P listed waste may be accumulated of P listed waste may be accumulated Must be moved to storage accumulation within 3 days Must be moved to storage accumulation within 3 days

after these quantities are reached (federal regulations)after these quantities are reached (federal regulations) Some states are stricterSome states are stricter


Storage AccumulationStorage Accumulation

Hazardous Waste Storage Accumulation Site:Hazardous Waste Storage Accumulation Site: Provides a safe and secure storage area for Provides a safe and secure storage area for

hazardous waste while it awaits shipping. hazardous waste while it awaits shipping. Same locked area as mercury, xylene, Same locked area as mercury, xylene,

formaldehyde, lab chemicalsformaldehyde, lab chemicals Maximum storage time: Maximum storage time:

90 days if LQG; 180 days if SQG90 days if LQG; 180 days if SQG


What Departments Get Involved What Departments Get Involved in Managing Pharmaceutical in Managing Pharmaceutical

Waste?Waste? PharmacyPharmacy NursingNursing Infection ControlInfection Control Environmental ServicesEnvironmental Services SafetySafety Facility ManagementFacility Management Risk ManagementRisk Management Materials ManagementMaterials Management


Considering the Optimal Considering the Optimal Management OptionsManagement Options

Need to label items that need segregation in a Need to label items that need segregation in a manner that makes it easy for pharmacy and manner that makes it easy for pharmacy and nursing personnelnursing personnel

Shelf stickers in pharmacyShelf stickers in pharmacy Data Applied to Dispensing Software and/orData Applied to Dispensing Software and/or Message inserted into automated dispensing Message inserted into automated dispensing

machines, etc. and MAR (Medication machines, etc. and MAR (Medication Administration Record) and/orAdministration Record) and/or

Stickers Applied Manually Stickers Applied Manually


Getting Implementation Done: Getting Implementation Done: Choosing a ModelChoosing a Model

Model 1: Automated sorting deviceModel 1: Automated sorting device In developmentIn development

Model 2: Labeling electronicallyModel 2: Labeling electronically Model 3: Labeling manuallyModel 3: Labeling manually Model 4: Central collection and sortingModel 4: Central collection and sorting Model 5: Manage all as hazardous wasteModel 5: Manage all as hazardous waste


Model 2: Electronic Labeling Model 2: Electronic Labeling

Entire inventory is analyzedEntire inventory is analyzed Shelf stickers in pharmacyShelf stickers in pharmacy Data is entered into the dispensing software at the NDC Data is entered into the dispensing software at the NDC

or “pneumonic” levelor “pneumonic” level Label prints with pre-determined codeLabel prints with pre-determined code

HW1, RCRA1, Black Bin, etc.HW1, RCRA1, Black Bin, etc. Nursing staff are trained on waste segregation based on Nursing staff are trained on waste segregation based on

codescodes Black “satellite accumulation” containers in soiled utility Black “satellite accumulation” containers in soiled utility

roomsrooms Hybrid Model: North Memorial Health Care Hybrid Model: North Memorial Health Care

Programmed automated dispensing machines (e.g., Pyxis)Programmed automated dispensing machines (e.g., Pyxis)


Model 3: Manual Labeling of Model 3: Manual Labeling of Hazardous WasteHazardous Waste

Entire inventory is analyzed Entire inventory is analyzed Shelf stickers in pharmacyShelf stickers in pharmacy Items are stickered upon dispensing Items are stickered upon dispensing Nursing staff are trained on waste segregation based on Nursing staff are trained on waste segregation based on

stickersstickers Black “satellite accumulation” containers in soiled utility Black “satellite accumulation” containers in soiled utility

roomsrooms Model program: North Memorial Health CareModel program: North Memorial Health Care

http://www.hospitalconnect.com/hfmmagazine/jsp/http://www.hospitalconnect.com/hfmmagazine/jsp/articledisplay.jsp?dcrpath=HFMMAGAZINE/articledisplay.jsp?dcrpath=HFMMAGAZINE/PubsNewsArticleGen/data/2006March/PubsNewsArticleGen/data/2006March/0603HFM_DEPT_EnvirSer&domain=HFMMAGAZINE0603HFM_DEPT_EnvirSer&domain=HFMMAGAZINE


North Memorial Health CareNorth Memorial Health CareRobbinsdale, MNRobbinsdale, MN

SPECIAL DISPOSALSPECIAL DISPOSALREQUIREDREQUIRED

Photos courtesy of North Memorial Health Care


Model 4: Centralizing Segregation Model 4: Centralizing Segregation

All pharmaceutical waste is collected in hazardous waste containers All pharmaceutical waste is collected in hazardous waste containers in the pharmacy and in the nursing unitsin the pharmacy and in the nursing units

The mixed waste is removed to the central hazardous waste storage The mixed waste is removed to the central hazardous waste storage accumulation areaaccumulation area

Sorting is done by hazardous waste vendor or trained hospital staff Sorting is done by hazardous waste vendor or trained hospital staff based on an analysis of the inventorybased on an analysis of the inventory

Hazardous waste and related items are manifested and disposed as Hazardous waste and related items are manifested and disposed as suchsuch

Model: Abbott Northwestern Hospital Model: Abbott Northwestern Hospital


Abbott Northwestern HospitalAbbott Northwestern HospitalMinneapolis, MNMinneapolis, MN


Model 5: Managing All Model 5: Managing All Pharmaceutical Waste as Pharmaceutical Waste as

HazardousHazardous Easiest, most expensiveEasiest, most expensive

May still need to sort out ignitablesMay still need to sort out ignitables

Still need to do analysis of inventory to Still need to do analysis of inventory to determine waste codes for manifestingdetermine waste codes for manifesting

Hybrid Model: UW Health, Madison, WI Hybrid Model: UW Health, Madison, WI All tablets/capsules/solids hazardousAll tablets/capsules/solids hazardous IVs hazardous if RCRA, PharmE HazardousIVs hazardous if RCRA, PharmE Hazardous®® (BMP) (BMP)


UW HealthUW HealthMadison, WIMadison, WI


SummarySummary Managing hazardous pharmaceutical waste is Managing hazardous pharmaceutical waste is

an emerging and rapidly evolving management an emerging and rapidly evolving management areaarea

Several implementation models are available Several implementation models are available and more may evolveand more may evolve

Successful implementation will require an Successful implementation will require an interdisciplinary team committed to moving interdisciplinary team committed to moving forwardforward

The rewards include cost-effective compliance The rewards include cost-effective compliance and evidence of a commitment to environmental and evidence of a commitment to environmental excellence excellence


ResourcesResources NIOSH Hazardous Drug AlertNIOSH Hazardous Drug Alert

http://www.cdc.gov/niosh/docs/2004-165/#sumhttp://www.cdc.gov/niosh/docs/2004-165/#sum ASHP Guidance on Handling Hazardous DrugsASHP Guidance on Handling Hazardous Drugs

http://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDFhttp://www.ashp.org/s_ashp/bin.asp?CID=6&DID=5420&DOC=FILE.PDF OSHA Technical ManualOSHA Technical Manual

http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.htmlhttp://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html Hospitals for a Healthy EnvironmentHospitals for a Healthy Environment

http://www.h2e-online.org/http://www.h2e-online.org/ Pharmaceutical waste webpage: Pharmaceutical waste webpage: http://www.h2e-online.org/hazmat/pharma.htmlhttp://www.h2e-online.org/hazmat/pharma.html Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care Facilities In the Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care Facilities In the

United States: United States: http://www.h2e-online.org/docs/h2epharmablueprint41506.pdfhttp://www.h2e-online.org/docs/h2epharmablueprint41506.pdf PharmEcology Associates, LLCPharmEcology Associates, LLC

www.pharmecology.comwww.pharmecology.com FAQs, state and federal waste regulations, subscription search engineFAQs, state and federal waste regulations, subscription search engine PharmE™ Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous PharmE™ Waste Wizard identifies RCRA hazardous waste plus NIOSH hazardous

drugs, among additional criteria drugs, among additional criteria Pharmaceuticals and Personal Care Products as Environmental Pollutants: Pharmaceuticals and Personal Care Products as Environmental Pollutants:

http://www.epa.gov/nerlesd1/chemistry/pharma/index.htmhttp://www.epa.gov/nerlesd1/chemistry/pharma/index.htm


Questions?Questions?

John Brenna, R. Ph.John Brenna, R. Ph.PharmEcology Associates, LLCPharmEcology Associates, LLC

[email protected]@pharmecology.comwww.pharmecology.comwww.pharmecology.com

414-292-3959414-292-3959


Pharmaceutical Waste Pharmaceutical Waste ManagementManagement

In which waste container should you discard In which waste container should you discard each of the following items?each of the following items?

What is the appropriate waste stream What is the appropriate waste stream designation for each?designation for each?

How should each item be destroyed?How should each item be destroyed?


Empty cyclophosphamide Empty cyclophosphamide IV bag IV bag

Yellow chemotherapy container Yellow chemotherapy container

Regulated Medical Waste Regulated Medical Waste

Incinerate only Incinerate only


Partial vial of paclitaxel Partial vial of paclitaxel

Black hazardous waste container– ignitable Black hazardous waste container– ignitable RCRA Hazardous WasteRCRA Hazardous Waste

Federally permitted Treatment, Storage and Federally permitted Treatment, Storage and Disposal FacilityDisposal Facility


Used chemo gown Used chemo gown



Incinerate onlyIncinerate only


Empty arsenic trioxide Empty arsenic trioxide ampuleampule

Black hazardous waste container – Black hazardous waste container – toxic toxic

RCRA Hazardous WasteRCRA Hazardous WasteFederally permitted Treatment, Storage Federally permitted Treatment, Storage

and Disposal Facilityand Disposal Facility


Contents of spill kit after a Contents of spill kit after a hazardous spill clean-up hazardous spill clean-up

Black hazardous waste container Black hazardous waste container – toxic – toxic

RCRA Hazardous WasteRCRA Hazardous WasteFederally permitted Treatment, Federally permitted Treatment, Storage and Disposal FacilityStorage and Disposal Facility


Partial Methotrexate IV Partial Methotrexate IV Black hazardous waste container – Black hazardous waste container –

toxictoxicBest Management PracticeBest Management PracticeRCRA Hazardous WasteRCRA Hazardous Waste

Federally permitted Treatment, Storage Federally permitted Treatment, Storage and Disposal Facilityand Disposal Facility


Expired Methotrexate Expired Methotrexate tabletstablets

(Original container) (Original container)

Reverse distribution Reverse distribution


Ziplock bag used to Ziplock bag used to transport chemotransport chemo





Needle & syringe used Needle & syringe used in IV chemo preparationin IV chemo preparation





Empty lindane bottle Empty lindane bottle

Municipal trash Municipal trash

LandfilledLandfilled

Copyright © 2007 by PharmEcology Associates, LLC John Brenna, R. Ph. Hospital Consultant...

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